Recall Z-1469-2022 ยท GKZ Counter, Differential Cell
SIGHT DIAGNOSTICS LTD
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
| Date | Jun 14, 2022 |
| Status | Open, Classified |
| Reason | The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range. |
| Root cause | Software Design Change |
| Action | On June 14, 2022, the firm notified customers via email of the recall. Customers were informed that a software correction for this issue will be included in any software version ABOVE 2.63.1.1. Pending the software correction through a version upgrade, the firm provided instructions to manually configure the correct default reference ranges on the device, which are also included in Section 2.5.4 of the Sight OLO Operator's Manual. Alternatively, you can contact support@sightdx.com and coordinate a time for Sight's technical support team to remotely update your device software. |
| Quantity | 72 US; 292 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and the c |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190898 | Sight OLO Sight Diagnostics , Ltd., Nov 1, 2019 |